Manager, Statistical Programming

🕒 July 22

🇺🇸 United States – Remote

💵 $133.2k - $172.4k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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Gilead Sciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1987

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Gilead Sciences is a leading biopharmaceutical company that focuses on discovering, developing, and delivering innovative therapeutics for patients with life-threatening diseases. The company is highly recognized for its contributions in virology, particularly HIV and hepatitis, and is actively expanding its therapeutic reach into fields like oncology and inflammation. Gilead has a strong pipeline of medicines, with over 25 products available globally and 50 clinical programs. Known for its commitment to health equity, the company also actively funds HIV research and causes. Gilead's dedication to scientific innovation and health equity aims to tackle the world's most pressing health challenges, improving patient lives globally.

📋 Description

• Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting• Serves as project leader• Generates or oversees the production of programming deliverables (e.g., tables, listings) for study reports and integrated summaries• Successfully interacts within Biometrics, with Clinical Development and Regulatory Affairs groups on a frequent basis• Actively share experience and discuss possible process enhancements at programming meetings• Recommends potential trainings• Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures• Responsible for all programming activities within a therapeutic project or equivalent• Implements strategic initiatives• Able to lead and manage multiple concurrent projects

🎯 Requirements

• Bachelor's Degree and Six Years' Experience OR Masters' Degree and Four Years' Experience• Degree in Biostatistics/Computer Science or equivalent• 6+ years of pharmaceutical/CRO experience• Prior experience in oncology, hematology, and cell therapy is strongly preferred• Knowledge of long term follow up trial knowledge strongly preferred• Hands-on experience in pivotal studies and/or regulatory submissions (NDA, BLA, MAA, etc.)• In-depth understanding of clinical programming and/or statistical programming processes and standards• In-depth understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH)• Extensive experience with statistical programming using the SAS software including development and use of SAS Macros• Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM)• Proven experience in leading programming activities

🏖️ Benefits

• company-sponsored medical, dental, vision, and life insurance plans• discretionary annual bonus• discretionary stock-based long-term incentives (eligibility may vary based on role)• paid time off